Alert On Pace Medical Temporary Pacemakers And PSAs

Notice Issued By MHRA After CE Marking Is Suspended

10.07.2014

The Medical and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert related to temporary pacemakers and pacing system analysers (PSA) manufacturing by Pace Medical, after the CE marking on such devices was suspended.

In a Medical Device Alert, the regulatory body stated that the CE marking on such products had been suspended due to quality system failings.

From April 9th 2014, Pace Medical has not been selling the devices, but remaining devices purchased by distributors before that date may still be sold to UK hospitals and servicing or devices can continue as previously.

The MHRA added that reusable temporary pacing cables from the manufacturer remain available for purchase after being validated for compatibility, although the compatibility of alternative cables has not yet received the same backing.

It is advised that anyone involved in the use of such devices should consult the manufacturer or other distributors for further information on the availability of cables.

Expert Opinion

This is another case which reflects that whilst we believe more could be done to improve regulation around medical products, the current regime remains effective in certain circumstances.

"It is vital that everyone involved in the distribution and use of these devices is aware of the terms of this notice and takes action where necessary to ensure such products are not used on patients.

"The safety of patients should always come first and it is vital that, where possible, lessons are learned from the issues highlighted in this case to improve standards of regulation of medical devices cross the board."

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